moderate to severely inflamed candidiasis of the skin MedDRA version: 20.0 Level: LLT Classification code 10007159 Term: Candidiasis of skin and nails System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Mecloderm Ointment
Pharmaceutical Form: Ointment
INN or Proposed INN: CLOTRIMAZOLE
CAS Number: 23593-75-1
Other descriptive name: CLOTRIMAZOLE
Concentration unit: mg/g milligram(s)/gram
Sponsors
Dermapharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women and men = 18 years of age - Written consent to study participation after thorough information of the patient through the investigator or another medical competent member of the study team - Diagnosis of candidiasis of the skin based on clinical symptoms - Positive mycological result of a swab revealing at least a moderate number of fungi, microscopically proven - Sum score of all clinical parameters (erythema, exudation, dysesthesia/burning, maceration) = 7 - At least moderate severity of inflammation parameters erythema and exudation (i.e. score value = 2) - For women of childbearing potential: Application of an highly effective contraceptive method during the whole study - For women of childbearing potential: Pregnancy test with negative result prior to study start Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - The treatment area exceeds 10% of the body surface - Topical treatment in the observation area during the last 7 days prior to study inclusion - Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster, varicella), lues or tuberculosis of the skin, inoculation reactions, rosacea or rosacea-like dermatitis, perioral dermatitis, acne, primary purulent skin infections (like e.g. folliculitis), atrophied skin, wounds, ulceration, suspected additional bacterial infection - Necessity of application of the study medication in the area around the eyes - Systemic treatment with antimycotics and/or glucocorticoids within the last 4 weeks prior to study inclusion - Known intolerance or hypersensitivity against clotrimazole or other imidazole antimycotics, betamethasone dipropionate or other glucocorticoids, or any of the other ingredients in the study medications - Other severe acute or chronic concomitant disease with severe impairment of the general condition - Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible - Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data - Reasonable doubt concerning the co-operation of the patient - Participation in another clinical study within the last 30 days prior to inclusion in this study - Participation in this study at an earlier date - Women with existing or intended pregnancy or during lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of efficacy and safety of a new ointment with clotrimazole (10 mg/g) and betamethasone dipropionate (0.64 mg/g) (Mecloderm®) in comparison with the authorised medicinal product Lotricomb® Ointment and the underlying vehicle of Mecloderm® in patients with moderately to severely inflamed candidiasis of the skin.;Secondary Objective: see E5 (endpoints);Primary end point(s): Number (percentage) of patients with treatment success (defined as sum score of clinical parameters = 2 and all individual score values = 1 and negative mycological result) at the main examination (EOT visit 3 after 14 days).;Timepoint(s) of evaluation of this end point: After 2 weeks treatment with the trial medication (EOT, visit 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change of the clinical symptom score between visits, and between EOT and final examination - Number (percentage) of patients with mycological success at EOT and at the final visit - Evaluation of therapeutic success at EOT by the investigator and by the patient - Evaluation of overall therapeutic success by the investigator at the final examination visit - Number (percentage) of patients with clinical relapse/re-infection at the final examination visit;Timepoint(s) of evaluation of this end point: Different, depending on the end point. Please see E.5.2. | — |
Countries
Germany
Contacts
Public ContactClinical Research Department
Dermapharm AG
Outcome results
None listed